FDAFDA · Food and drugs·Recall number Z-1789-2017
ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
Published April 19, 2017 · Recall initiated: March 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
- Lot
- Lot numbers: 72702 and 78567
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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